NEWS: HHS announces that a diagnostic test for coronavirus disease 2019 (COVID19) – designed for use in a diagnostic system that can process up to 1,000 tests in 24 hours – will receive advanced development support from PHEgov.
A diagnostic test for coronavirus disease 2019 - designed for use in a diagnostic system that can process up to 1,000 tests in 24 hours - will receive advanced development support from the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response .
"Early, rapid diagnosis is essential for clinicians and their patients to treat infections appropriately and take immediate action to help mitigate the spread of COVID-19," said BARDA Director Rick Bright, Ph.D."While the Centers for Disease Control and Prevention and our nation's public health laboratories are making valiant efforts in testing and surveillance of coronavirus infections, these labs could become overwhelmed as the number of suspected cases grows.
BARDA and Hologic expect that necessary development will be completed in a matter of weeks which then would allow the U.S. Food and Drug Administration to consider granting for the diagnostic test. An EUA facilitates the availability and use of medical products needed during public health emergencies.
This Panther Fusion system provides complete sample-to-result automation with minimal user interaction and offers a broad menu of FDA-cleared tests to detect common respiratory infections. This existing infrastructure and supply chain would allow for rapid scale-up of the COVID-19 diagnostic test if the FDA issues an EUA, which would increase access to testing for more U.S. patients and healthcare providers in the fight against COVID-19.
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